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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal CAY-1035327-1/25/1


Manufacturer FEI3009690622
Manufacturer NameDts Mg Co Ltd  
Manufacturer Address line 1402 Daugun Indus Town 275-29  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD03  
Importer's Product DescriptionGENOSYS EYECELL KIT, SERUM  
Refusal Date11-Sep-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx CAY-1035327-1/25/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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